| ITEM | STANDARD | RESULTS |
| Appearance | White crystalline powder Odorless | Conforms |
| Identification | IR spectrum HPLC chromatogram |
Conforms Conforms |
| Solubility | Freely soluble in Methanol and Ethanol, Soluble in acetonitrile and isopropanol, Practically insoluble in water | Conforms |
| Specific rotation | -25°~-29° | Conforms |
| Fluorine | 8.4%~10.2% | 9.5% |
| Related Substance | Impurity A ≤0.15% Impurity B ≤0.15% Impurity C ≤0.15% Impurity D ≤0.15% Impurity E ≤0.15% Impurity F ≤0.15% Any other single impurity≤0.10% Total Impurities≤0.80% |
0.06% 0.05% 0.03% 0.02% 0.03% 0.02% 0.05% 0.45% |
| Residue Solvents | Isopropanol≤5000ppm Dichloromethane≤600ppm Methyl tert-butyl ether≤5000ppm Acetic ether≤5000ppm |
50ppm 10ppm 15ppm 10ppm |
| Enantiomer | ≤0.1% | Conforms |
| Water | ≤5.0 % | 3.0% |
| Residue on ignition | ≤0.2% | 0.08% |
| Heavy Metals |
≤20ppm | <10ppm |
| Assay | 98.0%~102.0% | 99.6% |
